NCT05399459

Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 897 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Rimegepant 25 MG	Single dose of 25 mg orally disintegrating tablet of rimegepant
DRUG	Rimegepant 75 MG	Single dose of 75 mg orally disintegrating tablet of rimegepant
DRUG	Placebo	Matching placebo tablet

Timeline

• Start date: 2022-08-09
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2022-06-01
• Last updated: 2025-03-07
• Results posted: 2025-02-10

Locations

50 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study